[GENERIC NAME]

 Helicobacter Pylori(HP)Antigen Test Kit(Colloidal Gold).

[PACKAGE QUANTITY]

20 tests/kit,40 tests/kit.

[PACK TYPE]

 Gray cardboard box.

[APPLICATION]

For the clinical characterization of Helicobacter Pylori(HP) antigen in stool.

[TEST PRINCIPLE]

The function parts of the test kit are diluting liquid and test cards which contain immunological reagent on the chromatographic membrane. The stationary reagent line that has been applied onto the membrane in the test area (T) is otherwise invisible, but if the serum passes through membrane contains HP antigen to the specific HP antibody, the line turns distinctly red in the test area. The control line that has been put on the membrane in the control area (C) invisible before the test turns red during the assay process, thus indicates proper performance of the test device. Regardless of the existence of HP antigen in the sample, the control line will appear.

[MAIN COMPONENTS]

[STORAGE AND PERIOD OF VALIDITY]

Stored in a dry place at 2-30°C; 12 months.

[SAMPLE REQUIREMENTS]

Stool can be used as the sample for this test kit. Samples shall be stored refrigerated(2°C-8°C) for two days,also can be frozen(-20°C)for long-term storage,but avoid repeated freezing and thawing. Fresh sample is recommended.

[SUCCESSIVE OPERATING PROCEDURES]

1)Before using the kit,you must read this introduction,and make sure that the kit and samples were returned to room temperature.

2) Open the bottle which has extracting liquid, take one of the mung bean size (about φ 5 mm) of the stool sample using with the stick on the cap, then put it into extracting liquid and turn off the cap. Squeeze and shake the bottle hard for 2 minutes.

3) Take out one test card and make sure it should be used within an hour. The card should be put on the clean, dry, flat test stand. Break off the top of the cap. You just need to drop 2-3 drops sample extracting liquid in the sample hole (S).

4)Read the result in 15 minutes. The result is not acceptable after 20 minutes.

[RESULTS EXPLANATION]

1)A positive result(the antigen activity of the sample is above the cut-off level of the test)is indicated as a distinctly visible red line in the test area(T)and a red line in the control area(C).

2)A negative result(the antigen activity of the sample is below the cut-off level of the test)is indicated by the absence of a distinctly visible red line in the test area(T)and the presence of a red line in the control area(C).

3)An invalid result is indicated by the absence of a distinctly visible red line in the control area(C), this test should be repeat.

4)If there are two red lines in the test area(T)and control area(C),even though the red line in the test area(T)is very light,the positive result should be ruled .

[TEST LIMITATIONS]

1) Ideal test results should fully comply with the above testing procedures. Operation error may lead to incorrect results.

2) The test kit is for in vitro diagnostic use and the detection of antigen in stool samples only,the result is just a qualitative analysis , not a quantitative detection.

3) A positive result or a negative result just show that the antigen activity of the sample is above or below the cut-off level of the test,the result can not be used as the sole criterion of HP infection. If necessary,other methods or equipment are needed,Professionals should according to the further test results and clinical symptoms to make judgments.

[PERFORMANCE INDICATORS]

Positive compliance rate: ≥99%;

Intra batch discrepancy: ≤1%;

Inter batch discrepancy: ≤1%.